MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRBRD2 COBRAID 38 SNGL ARM PACK AS; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	7211081
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl procedure, the urgical instrumentalist broke the plastic wrap that covers the secondary packaging and when opening it, found that the primary packaging of the product was open, compromising the sterile condition.The secondary packaging did not have the standard smith-nephew seal, only the plastic wrap.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the product prints found packaging and seal specifications.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: ULTRBRD2 COBRAID 38 SNGL ARM PACK AS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10546327
• Report Number: 1219602-2020-01415
• Device Sequence Number: 1217742
• Product Code: GAT
• UDI-Device Identifier: 03596010547682
• UDI-Public: 03596010547682
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7211081
• Device Catalogue Number: 7211081
• Device Lot Number: 74G1903584
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1